- Device
- Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- Applicant
- ABBOTT MEDICAL
- PMA number
- P200049
- Supplement
- S004
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2022-07-28
- Decision code
- OK30
- Date received
- 2022-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternate laser cutting and welding systems used in the manufacturing of the Amplatzer Amulet Left Atrial Appendage Occluder.